A Real-world Chronic Myelogenous Leukemia (CML) Patient Disease Registry to Describe Patient Experience and Clinical Outcomes Among Patients With CML Receiving Approved First or Second Line Tyrosine Kinase Inhibitor (TKI) Therapy (ASC4REAL-2)

This CML disease registry (ASC4REAL-2) aims to gather evidence on the tolerability, safety, effectiveness, and patient-reported outcomes (PRO) in real-world healthcare from patients with Ph+-CML-CP treated with TKIs approved for 1L and 2L, including prospective follow-up for 5 years identifying and describing long-term treatment outcomes.

Study Overview

• Status: Recruiting
• Conditions: Chronic Myelogenous Leukemia - Chronic Phase
• Intervention / Treatment: Other: TKIs

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: 1-888-669-6682; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233-0271
      • Recruiting
      • University of Alabama at Birmingham
      • Principal Investigator: Omer Jamy
      • Contact: Phone Number: +1 205 502 9967
  • California
    • Stockton, California, United States, 95204
      • Recruiting
      • Stockton Hematology Oncology Medical Group Inc
      • Contact: Phone Number: +1 209 466 2626
      • Principal Investigator: Ravleen Grewal
    • Torrance, California, United States, 90509-2910
      • Recruiting
      • Lundquist Inst BioMed at Harbor
      • Principal Investigator: Sarah Elizabeth Tomassetti
  • Connecticut
    • Stamford, Connecticut, United States, 06902
      • Recruiting
      • Stamford Hospital
      • Principal Investigator: Joshua Dower
  • Florida
    • Pensacola, Florida, United States, 32504
      • Recruiting
      • Sacred Heart Medical Oncology
      • Principal Investigator: Dany El-Sayah
      • Contact: Phone Number: +1 850 416 2730
  • Maryland
    • Baltimore, Maryland, United States, 21229
      • Recruiting
      • St Agnes Hospital
      • Contact: Phone Number: +1 410 368 3412
      • Principal Investigator: Carole Miller
  • New York
    • East Setauket, New York, United States, 11733
      • Recruiting
      • NY Cancer and Blood Specialists
      • Principal Investigator: Adam Hines
    • Syracuse, New York, United States, 13210
      • Recruiting
      • SUNY Upstate Medical University
      • Principal Investigator: Gillian Kupakuwana-Suk
  • Ohio
    • Canton, Ohio, United States, 44718
      • Recruiting
      • Tri-County Hematology and Oncology Associates
      • Principal Investigator: Norman Rafique
  • Oregon
    • Salem, Oregon, United States, 97301
      • Recruiting
      • Oregon Oncology Specialists Salem
      • Principal Investigator: John Strother
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Recruiting
      • Avera Cancer
      • Contact: Phone Number: +1 605 322 3064
      • Principal Investigator: Tiffani Kirkpatrick
  • Texas
    • Temple, Texas, United States, 76502
      • Recruiting
      • Baylor Scott and White Research
      • Principal Investigator: Lucas Wong
      • Contact: Phone Number: +1 254 935 5838
  • Washington
    • Seattle, Washington, United States, 98109-1024
      • Recruiting
      • Fred Hutchinson Cancer Research Center
      • Principal Investigator: Vivian Oehler
      • Contact: Phone Number: +1 206 667 7315
    • Tacoma, Washington, United States, 98405
      • Recruiting
      • Northwest Medical Specialties
      • Contact: Phone Number: +1 253 428 8756
      • Principal Investigator: Ali Dadla
    • Tacoma, Washington, United States, 98405
      • Recruiting
      • MultiCare Health System Institute
      • Principal Investigator: Nehal Masood
      • Contact: Phone Number: +1 253 403 5265

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with Ph+-CML-CP who, at enrollment, are receiving 1 of 5 TKI treatments included in this registry either as initial therapy or after 1 prior TKI therapy.

Description

Inclusion Criteria:

• 18 years or older at the time of Ph+-CML-CP diagnosis.
• Receiving TKI treatment (asciminib, bosutinib, dasatinib, imatinib, or nilotinib) in routine medical care either as initial therapy or after 1 prior TKI therapy.
• Receiving treatment at US and US territories (i.e., Puerto Rico) medical practice (e.g. community-based, office-based, hospital-based, academic).
• Signed informed consent form (ICF) prior to participation in the study including agreement to be tokenized so that the patient's anonymized RWD (EMRs and/or claims data) can be accessed.

Exclusion Criteria:

• Active participation in an interventional trial that may influence the management of their Ph+-CML-CP disease.
• Currently being treated with a CML TKI in 3L or beyond.
• Known presence of T315I mutation.
• Currently in TFR phase and are not on active CML TKI therapy.
• Previously received treatment with a prior stem cell transplant
• Pregnant or nursing (lactating) female.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Asciminib; Patients who started their 1L or 2L asciminib following FDA approval on or after Oct-2024 OR Patients who have exited an asciminib interventional study in US for 1L/2L CML and are continuing treatment with asciminib in routine medical care	Other: TKIs; There is no treatment allocation for NIS trials. Patients administered TKI (asciminib, bosutinib, dasatinib, imatinib, nilotinib) by prescription will be enrolled.; Other Names: Scemblix, Bosulif, Sprycel, Gleevec, Tasigna
Bosutinib; Patients who started 1L or 2L bosutinib on or after Oct-2021	Other: TKIs; There is no treatment allocation for NIS trials. Patients administered TKI (asciminib, bosutinib, dasatinib, imatinib, nilotinib) by prescription will be enrolled.; Other Names: Scemblix, Bosulif, Sprycel, Gleevec, Tasigna
Dasatinib; Patients who started 1L or 2L dasatinib on or after Oct-2021	Other: TKIs; There is no treatment allocation for NIS trials. Patients administered TKI (asciminib, bosutinib, dasatinib, imatinib, nilotinib) by prescription will be enrolled.; Other Names: Scemblix, Bosulif, Sprycel, Gleevec, Tasigna
Imatinib; Patients who started 1L or 2L imatinib on or after Oct-2021	Other: TKIs; There is no treatment allocation for NIS trials. Patients administered TKI (asciminib, bosutinib, dasatinib, imatinib, nilotinib) by prescription will be enrolled.; Other Names: Scemblix, Bosulif, Sprycel, Gleevec, Tasigna
Nilotinib; Patients who started 1L or 2L nilotinib on or after Oct-2021	Other: TKIs; There is no treatment allocation for NIS trials. Patients administered TKI (asciminib, bosutinib, dasatinib, imatinib, nilotinib) by prescription will be enrolled.; Other Names: Scemblix, Bosulif, Sprycel, Gleevec, Tasigna

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of discontinuation of index TKI due to AEs	Rate of discontinuation of index Tyrosine kinase inhibitor (TKI) due to Adverse Events (AEs)	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overview of AEs	Overview of Adverse Events (AEs) to be provided	Up to 5 years
Rate and time to switches in TKI	Rate and time to switches in TKI to be provided	Up to 5 years
Time to discontinuation of TKI, and reasons for TKI treatment discontinuatio	Time to discontinuation of TKI, and reasons for TKI treatment discontinuation to be provided	Up to 5 years
Distributions of Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)	PRO-CTCAE provides assessment on individual symptom/side effect related to gastrointestinal signs/symptoms (diarrhea, constipation, nausea, vomiting), cardiovascular, sleep/wake, fatigue, headache, rash, muscle spasms, myalgia, joint pain, shortness of breath/coughing/chest pain, and edema. PRO-CTC AE scores range from 0 to 4 (4 stands for very severe)	Up to 5 years
Functional Assessment of Chronic Illness Therapy - Item-GP5 (FACIT GP5)	Functional assessment of chronic illness therapy - GP5 (FACIT-GP5): A single item question from the Functional Assessment of Cancer Therapy - General (FACT-G) that asks patients to rate the side effect bother on a 5 point Likert scale from "not at all" to "very much"	Up to 5 years
Distributions of the PRO instrument Patient-Reported Outcomes Measurement Information System Global Health-10 (PROMIS-GH-10)	The Global Health Patient-Reported Outcomes Measurement Information System (PROMIS-10) scale is a ten-item patient-reported measure that evaluates physical, mental, and social health. From the responses to the questions, two summary scores are derived: a global physical health score and a global mental health score. These scores are then normalised to the general population using the "T-score". The T scores range from 0 to 100 points, with 0 points indicating the most severe physical and/or mental impairment and 100 points representing the best possible health status.	Up to 5 years
Distributions of the PRO instrument Medication Adherence Report Scale - 10 (MARS-10)	Medication Adherence Report Scale - 10 (MARS-10): consists of 10 questions on forgetting, changing dosage, stopping, skipping, and taking less medication. Score ranges from 0 to 10, the higher the response the better the adherence to the medication.	Up to 5 years
Rates of molecular responses at/by specified timepoints	Rates of molecular responses at/by specified timepoints. MR1 is defined as Breakpoint cluster region (BCR)::Abelson (ABL1) ratio ≤ 10%; MR2 as BCR::ABL1 ratio ≤ 1%; MMR as BCR::ABL1 ratio ≤ 0.1%; MR4 as BCR::ABL1 ratio ≤ 0.01%; and MR4.5 as BCR::ABL1 ratio ≤ 0.0032%.	Up to 5 years
Duration of molecular responses	Duration of a specified molecular endpoint is defined as the time between the date of the first documented achievement of the specified molecular endpoint (on/after the first day of current TKI treatment) and the earliest date of loss of the specified molecular endpoint, treatment failure, progression to accelerated phase/blast crisis (AP/BC), or CML-related death for the patients in the analysis set who achieved molecular response at any time respectively. The duration will be censored at the last molecular assessment date while on treatment for patients who have not experienced any of the above events.	Up to 5 years
Rates of complete hematological response (CHR) at/by specified timepoints	CHR at specified timepoints are defined as the proportion of patients who achieve response at specified timepoints. For "by" timepoints, if a patient achieves a CHR and then loses it at or before the specified timepoint, he/she will still be classified as achieving CHR by that specific timepoint.	Up to 5 years
Failure-free survival (FFS)	FFS is defined as the time from the date of treatment start to the earliest occurrence of the following events: Treatment failure as defined below based on investigator or designee assessment irrespective of entry into the TFR period; Confirmed loss of MMR (in 2 consecutive tests, at any time while on treatment; Progression to BC as defined by the WHO (Khoury et al 2022); Death from any cause (including deaths observed during the survival follow-up period) For patients who have not experienced an event prior to or at the analysis cut-off date, the time will be censored at the date of last treatment or last assessment (whichever is later) or last post treatment follow-up.	Up to 5 years
Progression-free survival (PFS)	PFS is defined as the time from the date of treatment start to the earliest occurrence of the following events: progression to blastic phase; death from any cause	Up to 5 years
Overall survival (OS)	Overall survival (OS) is defined as the time from the date of treatment start to the date of death from any cause or end of follow-up period.	Up to 5 years

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2025
• Primary Completion (Estimated): April 20, 2033
• Study Completion (Estimated): April 20, 2033

Study Registration Dates

• First Submitted: July 14, 2025
• First Submitted That Met QC Criteria: July 28, 2025
• First Posted (Actual): July 29, 2025

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: dasatinib; adult,; quality of life,; registry,; nilotinib,; imatinib,; CML,; bosutinib,; CMP-CP,; ASC4REAL,; ASC4REAL-2,; chronic phase,; BCR-ABL, MMR,; TKI,; Tyrosine Kinase Inhibitor,; molecular response,; PRO,; patient reported outcome,; QOL,; asciminib,
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Chronic Disease; Disease Attributes; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia, Myeloid; Bone Marrow Diseases; Leukemia; Myeloproliferative Disorders; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Chronic-Phase; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Azoles; Hydrocarbons; Hydrocarbons, Cyclic; Carboxylic Acids; Hydrocarbons, Aromatic; Amides; Pyrimidines; Benzene Derivatives; Acids, Carbocyclic; Benzoates; Benzamides; Piperazines; Imatinib Mesylate; Dasatinib; nilotinib; asciminib; bosutinib
• Other Study ID Numbers: CABL001J1US01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO